Brown Fat Tissue Related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals

NCT ID: NCT05232695

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-02-01

Brief Summary

There are two types of adipose tissue in humans, white and brown adipose tissue. While the main task of white adipose tissue is energy storage, the main task of brown adipose tissue is energy expenditure. It was previously thought that only infants have brown adipose tissue, however today it is known that metabolically active brown adipose tissue exists in adult humans as well. Brown adipose tissue contributes to metabolic health through both energy expenditure and the cytokines they secrete.

Although obesity is frequently associated with many metabolic dysfunctions and cardiometabolic diseases such as insulin resistance, prediabetes, atherogenic dyslipidemia, metabolic syndrome, some obese individuals have been defined as metabolically healthy obese. The mechanisms underlying the formation of the metabolic healthy obese phenotype are not well understood. In experimental animal studies, it has been suggested that the molecular phenotype of adipose tissue is an important factor affecting metabolic health in obese individuals. One of the most important factors affecting the molecular phenotype of adipose tissue is the browning potential of adipose tissue. Based on this hypothesis, in this study it is aimed to investigate whether the browning of white adipose tissue has an effect on determining the metabolic phenotype of metabolically healthy and unhealthy obese individuals with the same amount of adipose tissue.

It is known that irisin, FGF21 and NRG4 are hormones that have the ability to brown the white adipose tissue. In our study, it was aimed to investigate whether there is a difference in serum FGF21, irisin and Neuregulin4 (NRG4) levels, which have brown adipose tissue browning potential, in metabolically healthy and unhealthy obese. In this way, it will be found out whether serum FGF21, irisin and NRG4 hormones, which have a browning effect on white adipose tissue, have an effect on the metabolic health of obese individuals and whether these hormones can be a treatment target.

In this project, participants who have BMI ≥30 kg/m2 and no criteria other than metabolic syndrome criteria, except increased waist circumference (blood pressure ≥130/85 mmHg, fasting blood glucose ≥100 mg/dl, triglyceride ≥150 mg/dl, HDL <40mg/dl in men, <50 mg/dl in women) and those without prediabetes will be defined as metabolically healthy obese, on the other hand other obese individuals will be defined as metabolic unhealthy. 10 ml blood samples will be taken from at least 60 metabolically healthy and 60 metabolically unhealthy participants. Serum FGF21, irisin and NRG4 levels will be measured and their levels in metabolically healthy and unhealthy obese individuals will be compared.

Conditions

Metabolically Healthy Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

metabolically healthy obese individuals

Individuals who have a body mass index equal or higher than 30 kg/m2, no medication usage, who have only high waist circumference without any other metabolic syndrome criteria.

metabolically healthy obese

Intervention Type: DIAGNOSTIC_TEST

Obese individuals will be divided into 2 groups as metabolic healthy and unhealthy obese, and their batokine concentrations will be compared.

metabolically unhealthy obese individuals

Individuals who have a body mass index equal or higher than 30 kg/m2, no medication usage, who have more than one metabolic syndrome criteria (as defined below) including high waist circumference.

metabolically healthy obese

Intervention Type: DIAGNOSTIC_TEST

Obese individuals will be divided into 2 groups as metabolic healthy and unhealthy obese, and their batokine concentrations will be compared.

Interventions

metabolically healthy obese

Obese individuals will be divided into 2 groups as metabolic healthy and unhealthy obese, and their batokine concentrations will be compared.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

metabolically unhealthy obese

Eligibility Criteria

Inclusion Criteria

• Body mass index ≥30
• Body fat percentage ≥30% in women, ≥25% in men

Exclusion Criteria

• antidiabetic medication usage
• antihypetrensive mediaction usage
• lipid lowering medication usage
• pregancy
• hypo/hyperthyroidism
• steroid usage
• benign/ malign tumor diagnosis
• liver disease
• secondary causes of obesity

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Hacer Hicran Mutlu

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hicran Mutlu, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital

Locations

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

White JD, Dewal RS, Stanford KI. The beneficial effects of brown adipose tissue transplantation. Mol Aspects Med. 2019 Aug;68:74-81. doi: 10.1016/j.mam.2019.06.004. Epub 2019 Jun 21.

Reference Type: BACKGROUND

PMID: 31228478 (View on PubMed)

Other Identifiers

Batokines-09

Identifier Type: -

Identifier Source: org_study_id